Senior Medical Writer

None • Foster City, CA, US • published 2026-09-23 05:43:16.119332

Description

**The Role:** The Medical Writer will serve as an important contributor to Sagimet Biosciences' Clinical and Regulatory Affairs teams, responsible for the creation, coordination, and delivery of high\-quality clinical and regulatory documents. Reporting directly to the Chief Medical Officer, this individual will lead the writing of clinical study reports, regulatory submissions, and scientific communications in support of the company's Phase II and Phase III clinical trial programs. The Medical Writer will bring a high degree of self\-direction, scientific acumen, and regulatory writing expertise to every deliverable. This role requires close collaboration with Clinical Operations, Biostatistics, Regulatory Affairs, and external CRO partners, as well as the ability to translate complex scientific data into clear, accurate, and submission\-ready documents that meet FDA, EMA, and ICH standards. **Essential Responsibilities:** * Author, edit, and finalize clinical study reports (CSRs) in accordance with ICH E3 guidelines for Phase II and Phase III clinical trials * Lead the writing of regulatory submission documents, including IND amendments, NDA/BLA sections, briefing documents, and ...

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